Background: This randomized, double-blind,
placebo-controlled trial examined the efficacy and safety of
risperidone in the treatment of aggression, agitation, and
psychosis in elderly nursing-home patients with dementia.

Method: Elderly patients with a DSM-IV diagnosis
of dementia of the Alzheimer's type, vascular dementia, or a
combination of the 2 (i.e., mixed dementia) and significant
aggressive behaviors were randomized to receive, for a period of
12 weeks, a flexible dose of either placebo or risperidone
solution up to a maximum of 2 mg/day. Outcome measures were the
Cohen-Mansfield Agitation Inventory (CMAI), the Behavioral
Pathology in Alzheimer's Disease (BEHAVE-AD) rating scale, and
the Clinical Global Impression of Severity (CGI-S) and of Change
(CGIC) scales.

Results: A total of 345 patients were randomized
to treatment with risperidone or placebo, and 337 patients
received at least one dose of study drug. The trial was completed
by 67% of patients in the placebo group and 73% of patients in
the risperidone group. The mean ± SE dose of risperidone was
0.95 ± 0.03 mg/day. The primary endpoint of the study, the
difference from baseline to endpoint in CMAI total aggression
score, showed a significant reduction in aggressive behavior for
risperidone versus placebo (p < .001). A similar improvement
was also seen for the CMAI total non-aggression subscale (p <
.002) and for the BEHAVE-AD total (p < .001) and psychotic
symptoms subscale (p = .004). At endpoint, the CGI-S and the
CGI-C scores indicated a significantly greater improvement with
risperidone compared with placebo (p < .001). Overall, 94% and
92% of the risperidone and placebo groups, respectively, reported
at least 1 adverse event. Somnolence and urinary tract infection
were more common with risperidone treatment, whereas agitation
was more common with placebo. There was no significant difference
in the number of patients who reported extrapyramidal symptoms
between the risperidone (23%) and placebo (16%) groups.